Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#218 of 1000 · 9,486 reports · 1991–2026
- BOOK 9,486 reports
- RANK #218 of 1000
- DEATH 9 death-typed
- INJ 6,246 injury-typed
- MALF 3,120 malfunction
- SPAN 1991–2026
- PEAK 2021: 1,218
- PHOTO Plate, Bone
Nearest event-volume peer: Plate, Bone (11 report gap)
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer sits #218 of 1000 among tracked device types with 9,486 MAUDE reports spanning 1991–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Event-type mix vs corpus
Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 65.8% corpus 30.4% · above corpus mean (+35.4 pp)
- MALF 32.9% corpus 64.5% · below corpus mean (-31.6 pp)
Lead product-problem code Break is 27% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 42% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Oxygenator
Oxygenator, Cardiopulmonary Bypass
9,642 reports
- Keratome
Keratome, Ac-Powered
9,574 reports
- Prosthesis (this)
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
9,486 reports
- Plate, Bone
Plate, Bone
9,475 reports
- Ring
Ring, Annuloplasty
9,471 reports
- Ventilator
Ventilator, Continuous, Non-Life-Supporting
9,447 reports
What this shows Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer carries 9,486 MAUDE reports, ranked #218 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Related Entities for Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Top Manufacturers
Event Locations
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Prosthesis, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (9,486 here).
Similar death-typed counts
Nearest other device types by death-typed report count (9 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Prosthesis are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Prosthesis; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.